Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418327
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2007-01-03
Brief Title:
Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Phase I Studies of TarcevaTM Erlotinib Hydrochloride OSI-774 as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to establish the recommended doseMaximum Tolerated Dose MTD of Tarceva in children as single agent and in combination with radiation therapy
Detailed Description:
Prognosis in relapsing malignant brain tumors is poor Those in brain stem gliomas is dismal median survival of these children does not exceed 9 months Radiation therapy may result in early and transient amelioration of symptoms but have not contributed to increase or prolong survival Moreover chemotherapy has not increased this outcome to datePrados et al reported encouraging results from a phase I study of TarcevaTMOSI-774 alone or with temozolomide TMZ in patients with malignant gliomas Of 25 evaluated patients 6 experienced PR 4 GBM glioblastoma multiforme and 1 grade 3 astrocytoma treated with TarcevaTM alone 1 GBM treated with TarcevaTMTMZ 2 had minor responses and 3 stable diseases These results in malignant glioma and the lack of efficacy in brain stem glioma with current treatment suggests the evaluation of this new therapeutic agent in children with relapsed brain tumors and upfront at diagnosis in brain stem glioma in combination with radiation therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None